When it comes to generic drugs, does the shape, color, or size of a pill influence whether patients take the medication as advised?
When it comes to generic drugs, does the shape, color, or size of a pill influence whether patients take the medication as advised?
FDA will survey about 3,000 pharmacists and consumers to determine the relationship between the physical appearance of generic drugs and medication adherence rates, a notice announced in the Federal Register.
Lawmakers investigating soaring generic drug prices
According to FDA, 85% of all drugs prescribed in the United States are generics. However, because distributors often change suppliers, patients can refill a prescription and receive medication that looks different. The FDA survey will attempt to determine whether those physical differences affect medication adherence.
“Studies indicate that patients are more likely to stop taking their generic medications when they experience a change in their drugs’ physical characteristics,” leading to harmful clinical and public health consequences, as well as increased health care costs, FDA wrote.
In the surveys, pharmacists will be asked how often they change suppliers for generic drugs, how they assist patients in switching between pills with different physical characteristics, and how patients respond to pill changes.
One of the patient surveys will focus on adults 50 years of age and older who have chronic conditions such as epilepsy, diabetes, hypertension, depression, and HIV. A second will concentrate on commercially insured patients who have experienced a change in pill characteristics.
Last year, FDA issued a draft guidance urging manufacturers to produce generic pills that are similar in size and shape to the brand-name drugs they replace.
FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.